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Associate Director

Location Shanghai Downtown, Shanghai Municipality, China Job ID R-075200 Date posted 02/21/2020

The Quality Assurance GxP accountabilities are split between the QA teams as below:

  • Audit and APAC team, GCP, GVP, GRP, LabGCP including strategy where applicable
  • GLP&RQA team GLP, HBS, GLS, LabGCP including strategy

    Audits

  • Plans, leads, conducts and reports audits in assigned GxP areas, and types e.g. investigator site audit, system or process audits and vendor audits
  • Participate in and may lead directed (For Cause) audits
  • Works with contract personnel or consultants to prepare, conduct and report outsourced audits
  • Supports Due Diligence activities as assigned

    Inspection Support

  • Collaborates with Quality Assurance Lead to manage and prepare for regulatory inspections, including providing pre- inspection training to the organisation as needed
  • Provides QA oversight and/or management of regulatory GxP inspections

    CAPA

  • Assesses need for, and assists in development of CAPA plans, approves and monitors plans to completion

    Job Specific General Accountabilities

  • Provides responsive and proactive quality and compliance advice to defined customers, effectively influence assigned area by being relevant GxP/quality system expert
  • Support quality and compliance risk management for functional area using risk framework standards to define risk and develop mitigation recommendations
  • Travel expected

    Quality Assurance General Accountabilities

  • Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
  • Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
  • Communicates effectively with QA colleagues and business stakeholders
  • Maintains knowledge of relevant industry information affecting quality and compliance arena
  • Leads training for colleagues and business stakeholders as required.
  • Involved in and may lead the development and/or revision of QA processes, projects and tools
  • Mentors QA colleagues
  • Provides general support related to regulatory authority inspections as and when required


AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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  • Compliance, Shanghai Downtown, Shanghai Municipality, ChinaRemove

Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.